Chronic PancreatitisESSENCENCT06655051
Single Plastic Stent Vs. Fully Covered Self-Expanding Metal Stent on Benign Biliary Stricture Secondary to Chronic Pancreatitis
A study testing endoscopic retrograde biliary drainage (single plastic stent) and endoscopic retrograde biliary drainage ( fully covered self-expanding metal stent) in people with Chronic Pancreatitis and Benign Biliary Stricture, run by Changhai Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the efficacy and safety of a single plastic stent versus a fully covered self-expanded metal stent in relieving benign biliary stricture secondary to chronic pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis, Benign Biliary Stricture
- What is being tested?
- endoscopic retrograde biliary drainage (single plastic stent) and endoscopic retrograde biliary drainage ( fully covered self-expanding metal stent)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older;
- Patients diagnosed with CP;
- Symptomatic biliary stricture documented at time of enrollment for naïve stricture or at the time of prior plastic stent placement in strictures that had 1 prior plastic stent inserted: cholangitis, and/or an increase in total bilirubin or alkaline phosphatase levels(> 2 times the upper limit of normal) for more than 4 weeks;
- Confirmation of bile duct stricture by imaging assessment.
Who cannot join
- Prior plastic stenting exceeding six months or any metal stenting;
- Incomplete removal of stones from the main pancreatic duct located in the head of the pancreas during ERCP procedures;
- Biliary stricture of benign etiology other than chronic pancreatitis;
- Developing obstructive biliary symptoms associated with an attack of acute pancreatitis;
- Stricture within 2 cm of common bile duct bifurcation;
- Biliary stricture of malignant etiology;
Show all 12Show fewer
- Patients with acute or chronic hepatitis, cirrhosis, primary sclerosing cholangitis, congenital biliary malformations or biliary fistula;
- Symptomatic duodenal stenosis (with gastric stasis);
- Subjects for whom endoscopic techniques are contraindicated;
- Pregnancy, incarceration;
- Life expectancy < 1 year;
- Other conditions that inappropriate to participant in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Changhai Hospital Clinical Research Ward
Shanghai, Shanghai Municipality, 200433
Lianghao Hu, M.D., lianghao-hu@hotmail.com
About this study
Official title: Efficacy and Safety of Single Plastic Stent Compared With Fully Covered Self-Expanding Metal Stent on Benign Biliary Stricture Secondary to Chronic Pancreatitis: A Single Center，Prospective，Non-inferiority, Open Label, Randomized, Controlled Trial
The goal of this clinical trial is to compare the efficacy and safety of a single plastic stent versus a fully covered self-expanded metal stent in relieving benign biliary stricture secondary to chronic pancreatitis. The main questions it aims to answer is:
Whether the efficacy of a single plastic stent is non-inferior to that of a fully covered metal stent in patients with benign biliary stricture secondary to chronic pancreatitis？
Participants will be randomly assigned to receive either a single plastic stent (SPS) placement or fully covered self-expanded metal stent placement treatment for 6 months, and they will be followed up for 18 months.
Read the detailed description
Although a number of previous studies have shown that the drainage and dilation effect of a single plastic stent is limited for benign biliary stricture (BBS) secondary to chronic pancreatitis (CP), the poor management of CP itself in most studies may explain the unsatisfactory efficacy of a single biliary plastic stent in relieving CP secondary BBS. Investigators believe that the effective management of CP is an important step to solve the BBS secondary to CP, especially the effective removal of pancreatic duct stones, the relief of pancreatic duct obstruction and the maintenance of pancreatic duct patency. Previous data showed that in CP patients treated with ESWL combined with ERCP, 72.4% could achieve complete removal of main pancreatic duct stones and 90.8% could achieve successful endoscopic decompression. Under the premise of effectively removing the stones of the main pancreatic duct at the head of the pancreas and maintaining the patency of the pancreatic duct, using a single plastic stent for stent drainage of BBS is effective, and a single plastic stent has potential advantages such as lower stent displacement rate and cheaper. Therefore, investigators design a single-center, prospective, open-label, randomized controlled, non-inferiority trial to compare the effectiveness, safety, and cost-effectiveness of a single plastic stent and fcSEMS for the removal of CP secondary BBS under the premise that the primary disease, i.e. CP itself, was effectively managed.
- Conditions
- Chronic Pancreatitis, Benign Biliary Stricture
- Being tested
- endoscopic retrograde biliary drainage (single plastic stent), endoscopic retrograde biliary drainage ( fully covered self-expanding metal stent)
- Keywords
- chronic pancreatitis, benign biliary stricture, ERCP, ERBD, stent
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic retrograde biliary drainage (single plastic stent)Device
Participants will undergo ERCP. A flexible tube is inserted into the duodenum, crossing the sphincter of Oddi to access the biliary system. And the location, diameter, and length of biliary stricture will be evaluated by injection of contrast media. A single plastic stent is then placed across the biliary stricture, allowing the bile duct to resume drainage. The participants will be observed closely after ERCP and record complications. Imaging evaluation will be conducted 6 months after stenting to confirm spontaneous passage of the biliary duct stent, and the stent will be removed via ERCP if it is still in place.
endoscopic retrograde biliary drainage ( fully covered self-expanding metal stent)Device
Participants will undergo ERCP. A flexible tube is inserted into the duodenum, crossing the sphincter of Oddi to access the biliary system. And the location, diameter, and length of biliary stricture will be evaluated by injection of contrast media. A fully covered self-expanding metal stent is then placed across the biliary stricture, allowing the bile duct to resume drainage. The participants will be observed closely after ERCP and record complications. Imaging evaluation will be conducted 6 months after stenting to confirm spontaneous passage of the biliary duct stent, and the stent will be removed via ERCP if it is still in place.
| Study group | Role | What they receive |
|---|---|---|
| Fully covered self-expanding metal stent | Active comparator | A single biliary fcSEMS will be placed under ERCP. During stenting period , if symptoms of biliary obstruction occur due to stent occlusion or migration, ERCP replacement or implantation of a new stent should be performed according to the condition. After 6 months of stenting, imaging evaluation will be performed. ERCP is not needed if the stent undergoes spontaneous complete distal migration and the patient is asymptomatic and has normal liver function. If the stent is visible, ERCP will be performed to remove the stent and the stricture will be evaluated. If stricture persists after 6 months of stenting, a follow-up treatment plan should be developed through multidisciplinary discussion. One month after ERCP, complications will be followed up by telephone. Follow-up after biliary stent removal will be conducted to inquire about symptoms, signs and liver function test results, and to evaluate the recurrence of biliary stricture. Receives: Device: endoscopic retrograde biliary drainage ( fully covered self-expanding metal stent) |
| single plastic stent | Experimental | A single biliary plastic stent will be placed under ERCP. During stenting period , if symptoms of biliary obstruction occur due to stent occlusion or migration, ERCP replacement or implantation of a new stent should be performed according to the condition. After 6 months of stenting, imaging evaluation will be performed. ERCP is not needed if the stent undergoes spontaneous complete distal migration and the patient is asymptomatic and has normal liver function. If the stent is visible, ERCP will be performed to remove the stent and the stricture will be evaluated. If stricture persists after 6 months of stenting, a follow-up treatment plan should be developed through multidisciplinary discussion. One month after ERCP, complications will be followed up by telephone. Follow-up after biliary stent removal will be conducted to inquire about symptoms, signs and liver function test results, and to evaluate the recurrence of biliary stricture. Receives: Device: endoscopic retrograde biliary drainage (single plastic stent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term stricture resolution
Stricture resolution assessed at the time of final stent removal as well as the absence of objective findings of stricture recurrence during the 18 months, post-stenting follow-up period.
Measured: 2 years after enrollment
Secondary outcomes (6)
Early clinical success
Stricture resolution at the time all stent is removed. If there is a persistent stricture after 6 months of stent therapy in either group, the patient will be classified as a clinical failure.
Measured: 6 months after enrollment
Technical success
The completion of the initial and each follow-up ERCP, including stent deployment and removal.
Measured: 6 months after enrollment
Adverse events related to the device or procedure
Device or procedure related adverse events from the initial stent placement procedure to the 2 year follow-up.
Measured: 2 years after enrollment
Length of stent placement and removal procedures
Length of stent placement procedures and stent removal procedures.
Measured: 6 months after enrollment
Number of ERCP procedures after Initial stent placement.
The number of endoscopic retrograde cholangiopancreatography (ERCP) procedures after initial stent placement.
Measured: 6 months after enrollment
Number of stents placed
The total number of stents placed
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start30 Apr 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Li, M.D., Study chair, Changhai HospitalLiang-Hao Hu, M.D., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655051
- Sponsor's protocol ID
- ESSENCE202405
- Acronym
- ESSENCE
- Status last verified
- May 2025
- First submitted
- 19 Oct 2024
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ramchandani M, Pal P, Costamagna G. Management of Benign Biliary Stricture in Chronic Pancreatitis. Gastrointest Endosc Clin N Am. 2023 Oct;33(4):831-844. doi: 10.1016/j.giec.2023.04.002. Epub 2023 May 11.
PubMed 37709414Dumonceau JM, Delhaye M, Tringali A, Arvanitakis M, Sanchez-Yague A, Vaysse T, Aithal GP, Anderloni A, Bruno M, Cantu P, Deviere J, Dominguez-Munoz JE, Lekkerkerker S, Poley JW, Ramchandani M, Reddy N, van Hooft JE. Endoscopic treatment of chronic pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Updated August 2018. Endoscopy. 2019 Feb;51(2):179-193. doi: 10.1055/a-0822-0832. Epub 2019 Jan 17.
PubMed 30654394Deviere J, Nageshwar Reddy D, Puspok A, Ponchon T, Bruno MJ, Bourke MJ, Neuhaus H, Roy A, Gonzalez-Huix Llado F, Barkun AN, Kortan PP, Navarrete C, Peetermans J, Blero D, Lakhtakia S, Dolak W, Lepilliez V, Poley JW, Tringali A, Costamagna G; Benign Biliary Stenoses Working Group. Successful management of benign biliary strictures with fully covered self-expanding metal stents. Gastroenterology. 2014 Aug;147(2):385-95; quiz e15. doi: 10.1053/j.gastro.2014.04.043. Epub 2014 May 4.
PubMed 24801350Haapamaki C, Kylanpaa L, Udd M, Lindstrom O, Gronroos J, Saarela A, Mustonen H, Halttunen J. Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis. Endoscopy. 2015 Jul;47(7):605-10. doi: 10.1055/s-0034-1391331. Epub 2015 Jan 15.
PubMed 25590182Cote GA, Slivka A, Tarnasky P, Mullady DK, Elmunzer BJ, Elta G, Fogel E, Lehman G, McHenry L, Romagnuolo J, Menon S, Siddiqui UD, Watkins J, Lynch S, Denski C, Xu H, Sherman S. Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1250-7. doi: 10.1001/jama.2016.2619.
PubMed 27002446Ramchandani M, Lakhtakia S, Costamagna G, Tringali A, Puspoek A, Tribl B, Dolak W, Deviere J, Arvanitakis M, van der Merwe S, Laleman W, Ponchon T, Lepilliez V, Gabbrielli A, Bernardoni L, Bruno MJ, Poley JW, Arnelo U, Lau J, Roy A, Bourke M, Kaffes A, Neuhaus H, Peetermans J, Rousseau M, Reddy DN. Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial. Gastroenterology. 2021 Jul;161(1):185-195. doi: 10.1053/j.gastro.2021.03.015. Epub 2021 Mar 17.
PubMed 33741314
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Single Plastic Stent Compared With Fully Covered Self-Expanding Metal Stent on Benign Biliary Stricture Secondary to Chronic Pancreatitis: A Single Center，Prospective，Non-inferiority, Open Label, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06655051
- Acronym / sponsor ID
- ESSENCE / ESSENCE202405
- Conditions
- Chronic Pancreatitis, Benign Biliary Stricture
- Keywords
- chronic pancreatitis, benign biliary stricture, ERCP, ERBD, stent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the efficacy and safety of a single plastic stent versus a fully covered self-expanded metal stent in relieving benign biliary stricture secondary to chronic pancreatitis. The main questions it aims to answer is:
Whether the efficacy of a single plastic stent is non-inferior to that of a fully covered metal stent in patients with benign biliary stricture secondary to chronic pancreatitis？
Participants will be randomly assigned to receive either a single plastic stent (SPS) placement or fully covered self-expanded metal stent placement treatment for 6 months, and they will be followed up for 18 months.
Detailed description
Although a number of previous studies have shown that the drainage and dilation effect of a single plastic stent is limited for benign biliary stricture (BBS) secondary to chronic pancreatitis (CP), the poor management of CP itself in most studies may explain the unsatisfactory efficacy of a single biliary plastic stent in relieving CP secondary BBS. Investigators believe that the effective management of CP is an important step to solve the BBS secondary to CP, especially the effective removal of pancreatic duct stones, the relief of pancreatic duct obstruction and the maintenance of pancreatic duct patency. Previous data showed that in CP patients treated with ESWL combined with ERCP, 72.4% could achieve complete removal of main pancreatic duct stones and 90.8% could achieve successful endoscopic decompression. Under the premise of effectively removing the stones of the main pancreatic duct at the head of the pancreas and maintaining the patency of the pancreatic duct, using a single plastic stent for stent drainage of BBS is effective, and a single plastic stent has potential advantages such as lower stent displacement rate and cheaper. Therefore, investigators design a single-center, prospective, open-label, randomized controlled, non-inferiority trial to compare the effectiveness, safety, and cost-effectiveness of a single plastic stent and fcSEMS for the removal of CP secondary BBS under the premise that the primary disease, i.e. CP itself, was effectively managed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fully covered self-expanding metal stent | Active comparator | Device: endoscopic retrograde biliary drainage ( fully covered self-expanding metal stent)A single biliary fcSEMS will be placed under ERCP. During stenting period , if symptoms of biliary obstruction occur due to stent occlusion or migration, ERCP replacement or implantation of a new stent should be performed according to the condition. After 6 months of stenting, imaging evaluation will be performed. ERCP is not needed if the stent undergoes spontaneous complete distal migration and the patient is asymptomatic and has normal liver function. If the stent is visible, ERCP will be performed to remove the stent and the stricture will be evaluated. If stricture persists after 6 months of stenting, a follow-up treatment plan should be developed through multidisciplinary discussion. One month after ERCP, complications will be followed up by telephone. Follow-up after biliary stent removal will be conducted to inquire about symptoms, signs and liver function test results, and to evaluate the recurrence of biliary stricture. |
| single plastic stent | Experimental | Device: endoscopic retrograde biliary drainage (single plastic stent)A single biliary plastic stent will be placed under ERCP. During stenting period , if symptoms of biliary obstruction occur due to stent occlusion or migration, ERCP replacement or implantation of a new stent should be performed according to the condition. After 6 months of stenting, imaging evaluation will be performed. ERCP is not needed if the stent undergoes spontaneous complete distal migration and the patient is asymptomatic and has normal liver function. If the stent is visible, ERCP will be performed to remove the stent and the stricture will be evaluated. If stricture persists after 6 months of stenting, a follow-up treatment plan should be developed through multidisciplinary discussion. One month after ERCP, complications will be followed up by telephone. Follow-up after biliary stent removal will be conducted to inquire about symptoms, signs and liver function test results, and to evaluate the recurrence of biliary stricture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older;
- Patients diagnosed with CP;
- Symptomatic biliary stricture documented at time of enrollment for naïve stricture or at the time of prior plastic stent placement in strictures that had 1 prior plastic stent inserted: cholangitis, and/or an increase in total bilirubin or alkaline phosphatase levels(> 2 times the upper limit of normal) for more than 4 weeks;
- Confirmation of bile duct stricture by imaging assessment.
Key exclusion criteria (12 listed)
- Prior plastic stenting exceeding six months or any metal stenting;
- Incomplete removal of stones from the main pancreatic duct located in the head of the pancreas during ERCP procedures;
- Biliary stricture of benign etiology other than chronic pancreatitis;
- Developing obstructive biliary symptoms associated with an attack of acute pancreatitis;
- Stricture within 2 cm of common bile duct bifurcation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic retrograde biliary drainage (single plastic stent)Participants will undergo ERCP. A flexible tube is inserted into the duodenum, crossing the sphincter of Oddi to access the biliary system. And the location, diameter, and length of biliary stricture will be evaluated by injection of contrast media. A single plastic stent is then placed across the biliary stricture, allowing the bile duct to resume drainage. The participants will be observed closely after ERCP and record complications. Imaging evaluation will be conducted 6 months after stenting to confirm spontaneous passage of the biliary duct stent, and the stent will be removed via ERCP if it is still in place. | Device | single plastic stent |
| endoscopic retrograde biliary drainage ( fully covered self-expanding metal stent)Participants will undergo ERCP. A flexible tube is inserted into the duodenum, crossing the sphincter of Oddi to access the biliary system. And the location, diameter, and length of biliary stricture will be evaluated by injection of contrast media. A fully covered self-expanding metal stent is then placed across the biliary stricture, allowing the bile duct to resume drainage. The participants will be observed closely after ERCP and record complications. Imaging evaluation will be conducted 6 months after stenting to confirm spontaneous passage of the biliary duct stent, and the stent will be removed via ERCP if it is still in place. | Device | Fully covered self-expanding metal stent |
Primary outcome
Long-term stricture resolution
Time frame: 2 years after enrollment
Stricture resolution assessed at the time of final stent removal as well as the absence of objective findings of stricture recurrence during the 18 months, post-stenting follow-up period.
6 secondary outcomes
Early clinical success
Time frame: 6 months after enrollment
Technical success
Time frame: 6 months after enrollment
Adverse events related to the device or procedure
Time frame: 2 years after enrollment
Length of stent placement and removal procedures
Time frame: 6 months after enrollment
Number of ERCP procedures after Initial stent placement.
Time frame: 6 months after enrollment
Number of stents placed
Time frame: 6 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Background: PubMed 37709414Ramchandani M, Pal P, Costamagna G. Management of Benign Biliary Stricture in Chronic Pancreatitis. Gastrointest Endosc Clin N Am. 2023 Oct;33(4):831-844. doi: 10.1016/j.giec.2023.04.002. Epub 2023 May 11.
- Background: PubMed 30654394Dumonceau JM, Delhaye M, Tringali A, Arvanitakis M, Sanchez-Yague A, Vaysse T, Aithal GP, Anderloni A, Bruno M, Cantu P, Deviere J, Dominguez-Munoz JE, Lekkerkerker S, Poley JW, Ramchandani M, Reddy N, van Hooft JE. Endoscopic treatment of chronic pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Updated August 2018. Endoscopy. 2019 Feb;51(2):179-193. doi: 10.1055/a-0822-0832. Epub 2019 Jan 17.
- Background: PubMed 24801350Deviere J, Nageshwar Reddy D, Puspok A, Ponchon T, Bruno MJ, Bourke MJ, Neuhaus H, Roy A, Gonzalez-Huix Llado F, Barkun AN, Kortan PP, Navarrete C, Peetermans J, Blero D, Lakhtakia S, Dolak W, Lepilliez V, Poley JW, Tringali A, Costamagna G; Benign Biliary Stenoses Working Group. Successful management of benign biliary strictures with fully covered self-expanding metal stents. Gastroenterology. 2014 Aug;147(2):385-95; quiz e15. doi: 10.1053/j.gastro.2014.04.043. Epub 2014 May 4.
- Background: PubMed 25590182Haapamaki C, Kylanpaa L, Udd M, Lindstrom O, Gronroos J, Saarela A, Mustonen H, Halttunen J. Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis. Endoscopy. 2015 Jul;47(7):605-10. doi: 10.1055/s-0034-1391331. Epub 2015 Jan 15.
- Background: PubMed 27002446Cote GA, Slivka A, Tarnasky P, Mullady DK, Elmunzer BJ, Elta G, Fogel E, Lehman G, McHenry L, Romagnuolo J, Menon S, Siddiqui UD, Watkins J, Lynch S, Denski C, Xu H, Sherman S. Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1250-7. doi: 10.1001/jama.2016.2619.
- Background: PubMed 33741314Ramchandani M, Lakhtakia S, Costamagna G, Tringali A, Puspoek A, Tribl B, Dolak W, Deviere J, Arvanitakis M, van der Merwe S, Laleman W, Ponchon T, Lepilliez V, Gabbrielli A, Bernardoni L, Bruno MJ, Poley JW, Arnelo U, Lau J, Roy A, Bourke M, Kaffes A, Neuhaus H, Peetermans J, Rousseau M, Reddy DN. Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial. Gastroenterology. 2021 Jul;161(1):185-195. doi: 10.1053/j.gastro.2021.03.015. Epub 2021 Mar 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhaoshen Li, M.D. study chair
Changhai Hospital
Liang-Hao Hu, M.D. principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic retrograde biliary drainage (single plastic stent) and endoscopic retrograde biliary drainage ( fully covered self-expanding metal stent) in people with Chronic Pancreatitis and Benign Biliary Stricture, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lianghao Hu, M.D. (+86-13817593520, lianghao-hu@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term stricture resolution (time frame: 2 years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06655051, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.